Product Development Scientist – Molecular

Description

Job purpose

The Product Development Scientist is responsible for the development of diagnostic molecular assays, including real-time PCR assays, through the R&D pipeline and working cross functionally to facilitate transfer, regulatory submission and commercialization.

Key duties and responsibilities

Assist in Product Development of Molecular and Immunoassays

• Collaborate with internal stakeholders to assist in defining product requirements, including performance specification and user needs for new products.
• Collaborate with the Director of Product Development and/or Senior Scientists to design and manage product development project plans, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams to facilitate efficient communication, alignment, and collaboration throughout the product development life cycle.
• Collaborate with Design Assurance & Regulatory Affairs staff to ensure compliance with relevant regulations, standards, and guidelines for new products.
• Collaborate with IMMY Make Teams to ensure seamless transfer of product designs into manufacturing processes.
• Collaborate with the Technical Project Manager to develop risk assessments and implement mitigation strategies to ensure safe and effective use of new products.
• Participate in product studies and user feedback sessions to gather insights and refine product designs.
• Stay abreast of advancements in the field of medical devices, fungal infections, and related technologies through continuous learning and professional development.

Perform Experiments to Develop and Verify Prototypes

• Design and execute experiments to create assay prototypes, optimize assay performance, and troubleshoot performance challenges.
• Develop molecular assays, including real-time PCR, through the product development process from ideation and conceptualization to prototyping, verification, and training of the IMMY Make Team.

Document Experiment Procedures and Results

• Contribute to the creation and maintenance of technical documentation, including product specifications and design control records.
• Create and maintain thorough and accurate experimental records.

Troubleshoot Experiment Procedures

• Design and execute experiments to troubleshoot performance challenges.

Maintain Lab Cleanliness

• Ensure the lab is maintained in a clean and organized condition to support efficient and safe research activities.

Qualifications

Required

· Bachelor's degree in science, molecular biology, biochemistry, biomedical engineering, or a related field.

· Minimum of 2 years of experience with molecular techniques, including DNA purification and PCR.

· Excellent problem-solving, analytical thinking, and decision-making skills.

· Strong communication and interpersonal skills.

· Ability to effectively present scientific data, results, and conclusions to stakeholders.

· Ability to work independently and collaboratively in a fast-paced, multidisciplinary environment.

Preferable

· Experience in product development, ideally in the medical device and IVD industry.

· Experience in molecular assay/immunoassay/lateral flow assay development

· Solid understanding of medical device development processes, including design controls.

· A proven track record of successfully bringing medical devices or related products to the market.

· Knowledge of fungal infections is advantageous.

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.